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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)
Classification Namestimulator, invasive bone growth
Generic Namesdpf implantable spinal fusion stimulator
ApplicantBIOMET, INC.
PMA NumberP850035
Supplement NumberS033
Date Received07/22/2008
Decision Date09/18/2008
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the trade name which was previously approved as: spf-plus (60/w) and spf- plus (60/m). The device will be marketed under the trade name spf plus-mini (60ua/w) and spf plus-mini (60ua/m) and is indicated as a spinal fusing adjunct to increase the probability of fusion success in 1 or 2 levels.
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